- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00700973
Treating Violence-Prone Substance Use Disorder Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Background:
Interpersonal violence (IPV) among substance use disorder (SUD) patients is common, undertreated, and costly. SUD patients have high rates of perpetrating IPV, and IPV is a risk factor for poor response to SUD treatment. Failure to address IPV among SUD patients interferes with treatment effectiveness and contributes to relapse and higher rates of health services use. Nonetheless, SUD treatment programs typically do not include violence prevention interventions and few studies have examined interventions designed to prevent violence perpetration among SUD patients.
Objectives:
This trial evaluated the effectiveness of an IPV-prevention (IPV-P) intervention among patients entering VA SUD treatment who had perpetrated violence in the past year against another adult. Primary objectives were to test the hypotheses that, compared to patients assigned to a control condition (CC), those assigned to IPV-P would (1) improve more on violence and SUD outcomes, and (2) use fewer VA mental health and medical care services, thereby saving costs for VA. Secondary objectives were to test the hypothesis that, compared to patients assigned to CC, those assigned to IPV-P would improve more on legal and alienation problems and social resources.
Methods:
Patients entering VA SUD treatment who met eligibility criteria (past-year violence; cognitively intact) and provided informed consent were assigned to SUD usual care plus either a CC (N=60) or IPV-P (N=59) intervention using a recurrent institutional design. That is, the IPV-P and CC conditions were run in alternate 3-month periods. The manualized IPV-P group intervention, based on a Cognitive-Behavioral approach, consisted of 8 in-person group sessions over 1 month, followed by telephone calls once a month for 3 months. The manualized CC was designed to control for non-specific treatment effects associated with the IPV-P condition, i.e., counselor time and attention, peer support, patients' expectations that additional sessions provide benefit. It consisted of 8 in-person group sessions over 1 month that reviewed material covered in usual SUD treatment, but with novel methods used to deliver the IPV-P intervention (role-play, homework, group activities). CC included the booster telephone sessions (once per month for 3 months). Participants were assessed at baseline and end-of-intervention (4 months post-baseline) and 6 and 12 months post-intervention (i.e., 10 and 16 months post-baseline) for primary and secondary outcomes and non-VA healthcare. Assessments consisted of the Addiction Severity Index (ASI, to assess Alcohol, Drugs, Psychiatric, and Legal functioning), the Conflicts Tactics Scale (CTS, to assess Psychological Aggression and Physical Assault against another adult), the Multidimensional Personality Questionnaire (MDQ, to assess Alienation, Stress Reaction, and Aggression), and the Life Stressors and Social Resources Inventory (LISRES, to assess family and friends resources). VA health care is being assessed with VA databases. Response rates at 4, 10, and 16 months were 90%, 79%, and 73%, respectively, and did not differ between the IPV-P and CC groups. Follow-up analyses compared the IPV-P to the CC group on outcomes using analyses of covariance that controlled for the baseline value of the outcome.
Status:
We are still completing portions of this project: (1) conducting mixed effects regression analyses to compare the CC and IPV-P groups on primary and secondary outcomes (these analyses are partially completed), and (2) using data on VA health care utilization to compare the two groups on VA health care costs (permission to download these data has been obtained, and we are working with HERC investigators to download and analyze the data).
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Entering VA substance use disorder treatment
- past-year violence
- cognitively intact
Exclusion Criteria:
- Not entering VA substance use disorder treatment
- no past-year violence
- cognitively not intact
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm 1
Substance use disorder usual care
|
Substance use disorder usual care
|
Experimentell: Arm 2
Interpersonal violence prevention intervention
|
This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Addiction Severity Index Legal Composite
Tidsram: One year post-intervention
|
Scores range from 0 to 1, with higher scores indicating more severe legal problems.
|
One year post-intervention
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Christine Timko, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Publikationer och användbara länkar
Allmänna publikationer
- Makin-Byrd K, Cronkite RC, Timko C. The influence of abuse victimization on attendance and involvement in mutual-help groups among dually diagnosed male veterans. J Subst Abuse Treat. 2011 Jul;41(1):78-87. doi: 10.1016/j.jsat.2011.02.001. Epub 2011 Mar 10.
- Timko C, Desai A, Blonigen DM, Moos BS, Moos RH. Driving while intoxicated among individuals initially untreated for alcohol use disorders: one- and sixteen-year follow-ups. J Stud Alcohol Drugs. 2011 Mar;72(2):173-84. doi: 10.15288/jsad.2011.72.173.
- Blonigen DM, Timko C, Moos BS, Moos RH. Impulsivity is an independent predictor of 15-year mortality risk among individuals seeking help for alcohol-related problems. Alcohol Clin Exp Res. 2011 Nov;35(11):2082-92. doi: 10.1111/j.1530-0277.2011.01560.x. Epub 2011 Jun 1.
- Timko C, Sutkowi A, Cronkite RC, Makin-Byrd K, Moos RH. Intensive referral to 12-step dual-focused mutual-help groups. Drug Alcohol Depend. 2011 Nov 1;118(2-3):194-201. doi: 10.1016/j.drugalcdep.2011.03.019. Epub 2011 Apr 22.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIR 07-264
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Substansrelaterade störningar
-
University of Southern DenmarkVejle Hospital; Vejle KommuneAvslutadHRQOL (Health Related Quality Of Life)Danmark
-
University of Southern DenmarkNaestved HospitalAvslutadHRQOL (Health Related Quality of Quality)Danmark
-
University of MalayaOkändTranspalatal Arch (TPA) | Oral Health Related Quality of Life (OHRQoL) | Oral Health Impact Profile Short Version 14 (OHIP 14) | Ortodontisk smärta | Tredimensionell (3D) ortodontisk anordningMalaysia
-
University of Nove de JulhoOkänd
-
Hospices Civils de LyonAvslutadNeuromyelit Optica Spectrum Disorders | Neuromyelit Optica Spectrum Related DisordersFrankrike
-
Shandong Suncadia Medicine Co., Ltd.RekryteringLipoprotein Disorder SjukdomKina
-
University of Kansas Medical CenterHar inte rekryterat ännuEsophagogastric Junction Disorder
-
Al-Azhar UniversityAvslutad
-
Assiut UniversityOkändTal Cortex Disorder
-
University Hospital, MontpellierAvslutadEustachian Tube DisorderFrankrike
Kliniska prövningar på Usual care
-
Albert Einstein College of MedicineColumbia University; University of Rochester; Rutgers UniversityAvslutadPediatrisk fetma | Karies i tidig barndomFörenta staterna
-
University of PennsylvaniaNational Cancer Institute (NCI); American Cancer Society, Inc.AvslutadFibros | Huvud- och halscancer | LymfödemFörenta staterna
-
Johns Hopkins UniversityHar inte rekryterat ännuGraviditetsdiabetes | Fetma, modernFörenta staterna
-
Johns Hopkins UniversityHar inte rekryterat ännuFetma, modern | Gestationell hypertoni | Preeklampsi; Komplicerar graviditeten | Eklampsi; Komplicerar graviditetenFörenta staterna
-
VA Office of Research and DevelopmentAvslutadPTSD | Posttraumatisk stressyndromFörenta staterna
-
Ohio State UniversityHar inte rekryterat ännuPostpartum depression | Postpartum ångest | Kardiometaboliskt syndromFörenta staterna
-
Karolinska InstitutetAktiv, inte rekryterandeBarnmisshandel | BarnmisshandelSverige
-
Massachusetts General HospitalNational Cancer Institute (NCI); Harvard Risk Management FoundationAvslutadCancer | Bröstcancer | Huvud- och halscancer | Schizofreni | Lungcancer | Bipolär sjukdom | Mag-tarmcancer | Allvarlig depressionFörenta staterna
-
Johns Hopkins UniversityJohns Hopkins Alliance for a Healthier WorldAktiv, inte rekryterande
-
Arkansas Children's Hospital Research InstituteAktiv, inte rekryterandePediatrisk astmaFörenta staterna